Coupler device for an endoscope

ABSTRACT

An endoscope accessory, such as a coupler device, is provided that includes a main body with a visualization section for allowing viewing of tissue by the endoscope and a proximal end configured for attachment to a distal end portion of the endoscope. The device includes a passage within the main body having an exit portal and a proximal end aligned with the working channel of the endoscope. An instrument passing through the passage is capable of angular adjustment relative to the main body of the coupler device by actuation of the endoscope.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/897,098 filed Jun. 9, 2020, which is a continuation of U.S. patentapplication Ser. No. 15/746,196 filed Jan. 19, 2018, issued as U.S. Pat.No. 10,856,724 on Dec. 8, 2020, which claims priority to InternationalPatent Application Serial No. PCT/US16/43371, filed Jul. 21, 2016, whichclaims the benefit of U.S. Provisional Application No. 62/195,291, filedJul. 21, 2015, all of which are hereby incorporated by reference for allpurposes as if copied and pasted herein.

FIELD

The present disclosure relates to a medical device, and moreparticularly to a device for covering and extending a working endportion of an optical imaging endoscope. The device provides a flexibleworking channel extension in communication with the working channel ofthe endoscope so that instruments can exit out of the working endportion at various angles, while also protecting the working end portionfrom ingress of bacteria, tissue, fluid, and other debris which couldlead to infection and decreased performance of the scope.

BACKGROUND

Recent advances in optical imaging technology have allowed many medicalprocedures to be performed today in a minimally invasive manner. Theevolution of the more sophisticated, flexible scope with advanced visualcapabilities has allowed access to regions deep within the human bodythat could only be achieved before with invasive surgical intervention.This modem day convenience has resulted in an increase in the demandfor, as well as the number of, endoscopic, laparoscopic, arthroscopic,ophthalmoscopic, borescopic, or other remote imaging visualizationprocedures performed every year in the U.S. While these procedures arerelatively safe, they are not without risks.

Endoscopy, for instance, is a procedure in which a lighted visualizationdevice called an endoscope is inserted into the patient's body to lookinside a body cavity or organ for the purpose of examination, diagnosisor treatment. The endoscope may be inserted through a small incision orthrough a natural opening of the patient. In a bronchoscopy, theendoscope is inserted through the mouth, while in a sigmoidoscopy, theendoscope is inserted through the rectum. Unlike most other medicalimaging devices, endoscopes are inserted directly into the organ.

Today, most endoscopes are reused. This means that, after an endoscopy,the endoscope goes through a cleaning, disinfecting or sterilizing, andreprocessing procedure to be introduced back into the field for use inanother endoscopy on another patient. In some cases, the endoscope isreused several times a day on several different patients.

While the cleaning, disinfecting and reprocessing procedure is arigorous one, there is no guarantee that the endoscopes will beabsolutely free and clear of any form of contamination. Modern dayendoscopes have sophisticated and complex optical visualizationcomponents inside very small and flexible tubular bodies, features thatenable these scopes to be as effective as they are in diagnosing ortreating patients. However, the trade off for these amenities is thatthey are difficult to clean because of their small size, and numerouscomponents. These scopes are introduced deep into areas of the bodywhich expose the surfaces of these scopes to elements that could gettrapped within the scope or adhere to the surface, such as body fluids,blood, and even tissue, increasing the risk of infection with eachrepeated use.

Endoscopes used in the gastrointestinal tract, especially specialtyendoscopes also known as duodenoscopes with a side-viewing capability,have an added complexity in that they are in a bacteria richenvironment. Typical duodenoscopes have internal moving components likean elevator with hinges attached to a cable for actuation. The elevatoris used to deflect and therefore change the direction of instrumentspassed down the scope's working channel. This elevator is beneficial inthat it can allow the user to change the direction of a wire or acatheter to direct the wire or catheter into a specific opening, so thatone or more instruments can be turned to enter a particular body lumen.However, given the size, location and movement of the elevator duringuse, the elevator creates cleaning issues, including the risk thatbacteria finds its way into the elevator's hinges and other hard toclean locations on the scope. This provides an opportunity for bacteriato colonize and become drug resistant, creating the risk of significantillness and even death for a patient. This infection risk is alsopresent in the cable mechanisms that are used to move the elevatormechanism back and forth and in other aspects of current scope designs.Moreover, in addition to the health risks posed by bacterialcontamination, the accumulation of fluid, debris, bacteria,particulates, and other unwanted matter in these hard to clean areas ofthe scope also impact performance, shortening the useful life of thesereusable scopes.

Accordingly, it is desirable to provide devices which serve asconvenient accessories for currently existing endoscopes to reduce therisk of contamination and infection, while also improving theperformance of the endoscope. It is particularly desirable to provide anaccessory for a duodenoscope that allows the user simultaneously toprotect the working end from bacterial contamination and also enableinstruments to exit out of the working end of the scope at differentangles with ease.

SUMMARY

The present disclosure provides a coupler device for covering andsealing a portion of the working end of a side viewing endoscope, with aflexible and tubular working channel extension that extends the workingchannel of the scope and can be angularly adjustable. The coupler deviceprotects the scope and its components, particularly the scope elevator,to reduce the risk of debris, fluid and other matter ending up in theelevator and behind the elevator and the working channel, potentiallycausing infection risk and, in some embodiments, the device has its ownway to articulate instruments, eliminating the need to have a scope withan elevator. The device may be single use disposable or reusable.

The coupler device may be provided as a single-use disposable accessoryto an endoscope that provides the user with the ability to change theangle of exit of a device being advanced out of the working channel ofan endoscope, without exposing the distal end of the scope to bacteria,debris, fluid and particulate matter. In some embodiments, the deviceattaches to the end of the endoscope and covers the working channel ofthe endoscope with a working channel extension in the coupler device,allowing an instrument to be passed down the working channel of theendoscope and into the working channel extension of the coupler device.The working channel extension can provide a seal against the scopeworking channel, so instruments can be passed back and forth through thescope working channel and out the working channel extension of thecoupler device without fluid and bacteria entering areas outside of thescope working channel. This seal is accomplished, in some embodiments,through an extension of the device working channel into the scopeworking channel, through a gasket on the end of the working channelextension, by way of a temporary glue, through pressure and the seal ofthe overall device against the distal end of the scope, through theselection of elastic and elastomeric materials, and other suitable andalternative means.

The working channel extension of the coupler device can be made of oneor more materials with elastic properties. The materials can includebiocompatible material(s) when the device is intended for medicalapplications, which may include, without limitation, elastic andelastomeric materials, as well as combinations of rigid and flexiblematerials, including silicone joined to polycarbonate and othermaterials joined to a biocompatible metal.

In some embodiments, the working channel extension of the coupler devicemay include an elastic biocompatible material that reduces the frictioninvolving in passing devices through the working channel extension,which is joined to a biocompatible metal, such as a coil spring, anadditional elastic material that is joined to the biocompatible metal,to improve flexibility, reduce kinking and aid in sealing the workingchannel of the device against the endoscope's working channel.

In some embodiments, the device allows the user to articulate theworking channel of the device in the direction preferred by the user ofthe endoscope, so that a wire, catheter or other instrument beingadvanced down the working channel of the endoscope can direct the wireor catheter or other instrument in a preferred direction different thanthe angle at which the instrument would exit the endoscope if thecoupler device was not in place or if an elevator in the scope is notused. This redirection of an instrument has the benefit of assistingwith the navigation of the device, while not allowing fluid, debris,particulate matter, bacteria and other unwanted elements to enter hardto clean areas of the endoscope, especially at the distal end of theendoscope.

The benefits of the invention include allowing the physician to changethe angle of exit, so that one or more devices can be turned to enter aparticular body lumen, such as a biliary duct or pancreatic duct, orother hard to reach area, including in non-medical procedures, whilesealing the distal end of the scope to prevent infection and theintrusion of debris and particulate matter into interior elements of thescope that are hard to reach to effectively clean.

In some embodiments, the device may be formed of an optically clearmaterial that covers the end of the endoscope and seals the end of theendoscope, allowing visualization of the endoscope's camera withoutobscuring the view by the device. The optically clear material may alsocover the endoscope's light guide to allow the light projected by theendoscope to illuminate the field of view of the endoscope. In someembodiments, the optically clear material may include navigation markersto orient the user when visualizing tissue, such as markers to identifythe relative position of the scope as the user visualizes the tissuethrough the optically clear material.

In embodiments, the optically clear material may also include othermarkers to guide the user with confirmation of the accurate placement ofthe optically clear material over the endoscope's camera and, ifapplicable, over the endoscope's light guide.

In some embodiments, the device may articulate instruments through thedevice through a cable in a sealed sheath that is attached to theflexible working channel extension in the coupler device, allowing theuser to advance and retract the cable to move the working channelextension backward and forward to change the angle of exit from theflexible working channel in order to direct an instrument to a desireddirection.

In some embodiments, the device may have multiple cables so the angle ofexit can be articulated in multiple directions, including in differentquadrants, unlike with the current endoscope elevators, which can onlydeflect and therefore redirect an instrument in a single axis due to thelimited travel of endoscope elevators, which can only be raised orlowered, but not moved from side to side or articulated into otherquadrants. In some embodiments, the cable(s) may be attached directly tothe working channel extension or to other devices that can bearticulated and cause the working channel extension to change its angleof exit, including, for example, a dowel underneath the working channelextension, but encased in the device that can be advanced forward andbackward to move the working channel extension as the cable is advancedand retracted. In some embodiments, the articulation ability of thecoupler device may be created with an elevator embedded in the couplerdevice, which is disposable and therefore thrown away after theprocedure.

The articulation ability of the coupler device may also take place withelements that do not involve cables, including for example, piezoelectric materials, micro motors, organic semiconductors, andelectrically activated polymers. In some embodiments, the articulationability of the coupler device may also take place with the transfer offorce to the working channel extension or an embedded elevator throughinterlocking connectors that transfer force, wires that twist, slidablesheaths, and memory metals that change shape through the transfer oftemperature. In some embodiments, the device includes a power connectoror motors to deliver energy, including electromagnetic energy, to thedevice to cause a transfer in force to change the angle of exit from thecoupler device as an instrument is passed through the device, or inadvance of passing an instrument through the device. This transfer offorce can include causing the device to rotate as it exits the workingchannel extension. The device may be navigated and articulated by theuser directly, or as part of a robotic system in which the users inputis translated through the system through various means, includingcables, power connectors, motors, electromagnetic energy, slideablesheaths, haptics, computer-guided and directed input, and other means todirect and guide the device to its intended location, including tospecific diagnosis and treatment objectives in a patient, or innon-medical applications, to a desired remote location.

In some embodiments, the device may be integrated into a scope andconfigured to be detachable and reusable for separate cleaning,including manual cleaning, in an autoclave, an ETO sterilizer, gammasterilizer, and other sterilization methods.

The articulation aspect of the coupler device may include a lockingfeature or capability to affix the angle of exit in the working channelextension at a specific angle. In some embodiments, the specific angleof exit may be aimed at a specific point in the gastrointestinal tract,such as a biliary or pancreatic duct, or the angle of exit may beaffixed so that a wire or other instrument inside the working channeltemporarily cannot be advanced, locking the instrument in positiontemporarily to aid in the exchange of instruments or to improvenavigation of the instrument temporarily.

The device may include a disposable or reusable control mechanism thatattaches to the endoscope to articulate the distal end of the couplerdevice to change the angle of exit from the working channel extension ofthe coupler device. In some embodiments, this control mechanism may alsolock the angle of exit of the working channel extension or the workingchannel extension may be locked through elements in the endoscopeitself, such as the elements that articulate the endoscope's elevator.

In some embodiments, the coupler device may cover the entire distal endof the endoscope, or may just cover hard to clean areas. In someembodiments, the coupler device may cover the distal end of theendoscope, or a portion thereof, or it may include a sheath attached tothe coupler device which covers the entirety of the scope that isexposed to fluid, debris, particulate matter, bacteria and otherunwanted elements.

In some embodiments, the device includes an anti-infective material. Inanother exemplary embodiment, the device includes an anti-infectivecoating. In still another embodiment, the device includes a coating thatis hydrophobic. In yet another embodiment, the device issuperhydrophobic. In even still another embodiment, the device isanti-infective and hydrophobic. Further yet in another embodiment, thedevice is anti-infective and superhydrophobic. In further still anotherexemplary embodiment, anti inflammatory coatings are incorporated intothe device.

The device may include a silver ion coating and a silver hydrogelapplied, infused or made part of the device in the area that covers orgoes around the scope elevators. The device may also include a valve orother element at the distal end of the catheter channel and may inembodiments have a valve in the working channel extension to preventhaving fluid and debris traveling from the lumen back into the scopeworking channel.

The device may include an electrical wire or other power transmissionpoint to enable the creation of an electrical field across a silver ioncoating to improve the activity of the silver ion coating or othercoating to prevent infection.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the disclosure. Additional features of thedisclosure will be set forth in part in the description which follows ormay be learned by practice of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of thedisclosure and together with the description, serve to explain theprinciples of the disclosure.

FIGS. 1A AND 1B are isometric views of an exemplary embodiment of thecoupler device of the present disclosure in use with a duodenum scope.

FIGS. 2A and 2B show partial cutaway views of the coupler device and aduodenum scope of FIGS. 1A AND 1B, respectively.

FIG. 3 shows another cutaway view of the coupler device and a duodenumscope of FIGS. 1A AND 1B.

FIG. 4 shows still another cutaway view of the coupler device and aduodenum scope of FIGS. 1A AND 1B.

FIG. 5 is a cutaway side view of the coupler device and a duodenum scopeof FIGS. 1A AND 1B in a first position.

FIG. 6 is a cutaway side view of the coupler device and a duodenum scopeof FIGS. 1A AND 1B in a second position.

FIG. 7 is a cutaway side view of the coupler device and a duodenum scopeof FIGS. 1A AND 1B in a third position.

FIG. 8 is an enlarged side view of the working channel extension withmembrane of the coupler device of FIGS. 1A AND 1B.

FIG. 9 is a top-down view of the coupler device of FIGS. 1A AND 1B.

FIG. 10 is a cutaway view of another exemplary embodiment of a couplerdevice of the present disclosure.

FIG. 11 is a cutaway side view of the coupler device of FIG. 10 .

FIG. 12 is a cutaway side view of the coupler device of FIG. 10 in usewith a duodenum scope.

FIG. 13 is an enlarged side view of an exemplary embodiment of a workingchannel extension of the present disclosure.

FIG. 14 is another enlarged side view of the working channel extensionof FIG. 13 .

FIG. 15A is a perspective view of the working channel extension of FIG.13 and FIG. 15B shows the working channel extension of FIG. 15A in usewith an instrument.

FIG. 16 is a perspective top-down view of the coupler device of FIG. 1with a locking feature.

FIG. 17 is a perspective view of another exemplary embodiment of aworking channel extension of the present disclosure.

DETAILED DESCRIPTION

Turning now to the drawings, FIGS. 1A and 1B illustrate an exemplaryembodiment of a coupler device 10 of the present disclosure. The couplerdevice 10 serves as an accessory component for currently existingendoscopes. The device seals and covers infection prone areas of thescope to prevent ingress of debris, fluid, or other unwanted matter thatcould lead to bacterial contamination and decreased performance of thescope. In addition, the coupler device 10 provides a flexible workingchannel for instruments to be inserted into the scope. The flexibleworking channel can be angularly adjustable with ease. As shown, thecoupler device 10 may be used with a duodenum scope 40 or otherside-viewing scope instrument. It is understood, of course, that thecoupler device 10 may be adapted for use with end viewing scopes aswell. In addition, the coupler device 10 of the present disclosure canbe used with all types of scopes for different medical applications. Theduodenum scope 40 shown here is merely for illustrative purposes.

As FIGS. 1A and 1B illustrate, the coupler device 10 may comprise a mainbody 12, proximal end 14 and distal end 16, lower surface 18 and uppersurface 20. The proximal end 14 attaches onto a working end of aduodenum scope 40, extending the working end portion of the scope 40.The upper surface 20 may include a lens and light guide 24 and a scopewasher opening 28, which is used to push fluid across the scope camerato wash debris off the camera and is also used to push air across thecamera to dry the camera and insufflate the patient's gastrointestinaltract. In addition, the upper surface 20 includes a flexible workingchannel region 30 that includes a flexible working channel extension 34that is surrounded by a flexible membrane 38. This flexible membrane 38serves as a protective hood or covering for the working end of thecoupler device 10, providing for flexible articulation while sealing outdebris, fluid, bacteria or other unwanted matter.

As shown in FIGS. 2A and 2B, the duodenum scope 40 may comprise a lightguide 44, lens 46 and washer opening 48. The coupler device 10cooperates with each of these components of the scope 40 to provide afully functioning scope. The coupler device 10 does not interfere withthe scope's ability to emit a clear image, but instead reduces the riskof contamination with each use. This benefit is achieved by providing acoupler device 10 which attaches to the working end components of thescope 40, and seals around the working end.

As further shown in FIGS. 1A, 1B 2A, 2B, 3 and 4, the coupler device 10provides an extension of the scope's working channel 42. The workingchannel extension 34 of the coupler device 10 in FIG. 1 is flexible andmay contact the scope's working channel 42 by a sealed connection, asshown in FIG. 4 , at the proximal end 34 a of the working channelextension. The distal end 34 b of the working channel extension 34serves as an exit portal for instruments to pass through the scope 40 toreach different areas of the body.

Additionally, the coupler device 10 provides a further seal around theelevator 50 of the scope. Because the coupler device 10 seals theelevator 40, risk of debris influx, fluids, bacteria and other matterbuild up behind the elevator and working channel is reducedsignificantly. This influx of debris, bacteria and other matter isbelieved to be the reason for drug resistant infections with currentscopes today. While preventing influx, the coupler device 10advantageously maintains flexibility to move the working channelextension 34.

In use, the scope's working channel extension 34 permits passage ofinstruments down the scope working channel 42 and through and out theworking channel extension 34 of the device 40 for assessment andtreatment of tissue and other matter. Such instruments may includecannula, catheters, stents and stent delivery systems, papillotomes,wires, other imaging devices including mini-scopes, baskets, snares andother devices for use with a scope in a lumen. This working channelextension 34 is flexible enough that the elevator 50 of the scope 40 canraise and lower the working channel extension 34 so that instruments canbe advanced down and out of the working channel extension distal end (orexit portal) 34 b of the scope 40 at various angles, or be raised andlowered by a cable or other means to articulate the working channelextension 34.

As FIGS. 5 to 7 illustrate, in use when the elevator 50 of the scope 40is actuated, the flexible working channel extension 34 of the couplerdevice moves or adjusts to this actuation, along the direction A-A InFIG. 5 , the elevator 50 is raised slightly, creating a hinged ramp orshoulder that pushes the working channel extension 34 a correspondingangle and shifts the exit portal or distal end 34 b of the workingchannel extension to the left. In FIG. 6 the elevator is raised higherthan in FIG. 5 , such that the distal end 34 b of working channelextension 34 is likewise shifted further to the left in comparison toFIG. 5 , while FIG. 7 shows the elevator 50 raised even higher and thedistal end 34 b of working channel extension 34 moved to the left evenfurther in comparison to FIGS. 5 and 6 .

As FIG. 8 shows, the ability of the distal end 34 b of working channelextension 34 to shift along the width of the working channel region 30of the coupler device 10 is in part due to the fact that the distal end34 b is itself attached to a flexible membrane 38. This flexiblemembrane 38 comprises a plurality of loose folds or creases, allowingthe excess material to stretch and bend as the elevator actuation forcesthe working channel extension to bend and shift in response. Inaddition, the flexible membrane 38 acts as a protective cover or hoodfor the working channel region 38, preventing the ingress of fluids,debris, or other unwanted matter from getting inside the scope 40 andcausing a bacterial contamination or the infusion of other unwantedfluid, debris or particulate matter.

It is contemplated that the coupler device 10 of the present disclosuremay be configured for single, disposable use, or it may be configuredfor reuse. The coupler device 10 may be made of any biocompatiblematerial, such as for example, silicone or another elastic or polymericmaterial. In addition, the material may be transparent. As shown in FIG.9 , the coupler device 10 may be formed of a transparent material toprovide a transparent covering of the scope camera and light source,thereby allowing unhindered performance of the scope 40.

FIGS. 10 to 12 show another exemplary embodiment of a coupler device 10of the present disclosure. In this embodiment, the coupler device 10 isadapted for use with scopes that are actuated by cable and eliminatesthe need for the elevator component. As illustrated, the coupler device10 maintains the same structural features as previously described, butnow includes a further disposable external sheath 60 that can receive aninterior actuating cable 54 of the scope. This cable 54 can be detachedfrom the elevator and reattached to the flexible working channelextension 34 of the coupler device 10. The elevator is no longer neededin this embodiment, as actuation of the cable effects movement of theworking channel extension 34. The external sheath 60 may be configuredto attach directly to the scope 40, such as by winding around theoutside of the scope or by a friction fit connection. In embodiments,multiple cables may be included in one or more sheaths to provide forarticulation in other quadrants than the single axis articulation withelevators in current duodenoscopes.

In other embodiments, the coupler device 10 may also include a closableport (i.e., self-sealing) that allows for the injection ofanti-adhesion, anti-bacterial, anti-inflammatory or other drug orinfusible matter that prevents the adherence or colonization of bacteriaon the scope. An applicator may be provided that is integrated into thecoupler device 10 with a port for delivery of the infusible matter.Alternatively, the applicator may be separate from the coupler device 10and applied to the distal end of the scope 40. The infusible matter mayinclude forms of silver, including in a gel or other solution, platinum,copper, other anti-adhesion, anti-bacterial, anti-inflammatory or otherdrug or infusible matter that is compatible with the scope and couplerdevice materials and biocompatible for patient use.

In one exemplary embodiment, the device includes an anti-infectivematerial. In another exemplary embodiment, the device includes ananti-infective coating. In still another embodiment, the device includesa coating that is hydrophobic. In yet another embodiment, the device issuperhydrophobic. In even still another embodiment, the device isanti-infective and hydrophobic. Further yet in another embodiment, thedevice is anti-infective and superhydrophobic. In further still anotherexemplary embodiment, anti inflammatory coatings are incorporated intothe device.

In one exemplary embodiment, the device 10 may include a silver ioncoating. In another embodiment, the device 10 may have a silver hydrogelapplied, infused, or made part of the device 10 in the area that coversor goes around the scope elevators. In addition to silver havingantimicrobial properties, silver can also conduct electricity. Thus, instill another embodiment, the device 10 may include an electrical wireor other power transmission point to enable the creation of an electricfield across the silver ion coating to improve the ability of the silverion coating to prevent infection. In some embodiments, the electricalwire or other power transmission point may also apply to otherantimicrobial and conductive materials, including platinum and copper.

FIGS. 13 and 14 show another embodiment of the working channel extension134 of the present disclosure. As contemplated, the working channelextensions may comprise a combination of different materials. Forexample, as shown in FIG. 13 , the working channel extension 134 may beformed of multiple elastic materials joined to a biocompatible metal. Insome embodiments, one of the elastic materials may be PTFE and anotherelastic material may be a biocompatible elastic material that covers thebiocompatible metal. In the example of FIG. 13 , the working channelextension 134 may comprise an inner elastic material 110 and an outerelastic material. The outside of the working channel extension 134 mayinclude a biocompatible metal 130, which may take the form of a coil orwinding 132. In one embodiment, the biocompatible metal may beencapsulated by one or more of the elastic materials.

In FIG. 14 , the outer biocompatible elastic material 120 is formed tocreate a gasket 122 to seal the proximal end of the working channelextension against 134 the working channel of an endoscope, creating aseal to prevent the intrusion of unwanted bacteria, biomatter and othermaterial into this sealed area.

In FIG. 15A, a working channel extension 134 is shown with an adjustableangle of exit 8 for locking an instrument 100 in place. In thisembodiment, when the angle of exit 8 is adjusted, it creates compressiveforce in the working channel 134, locking an instrument 100 in place, asshown in FIG. 15B. This can be used to fixate an instrument while a wireis advanced through the instrument, or to fixate a wire, while a secondinstrument is exchanged over the wire.

In FIG. 16 , an alternative embodiment is shown for locking aninstrument 100 in place. In this embodiment, the working channelextension 134 is raised to a point in which the instrument 100 in theworking channel extension 134 is compressed against a lock 80 on thedevice 10, causing a change in the angle of exit of the working channelextension 134 and locking the instrument 100 in a fixated place in theworking channel extension 134.

In FIG. 17 , an alternative embodiment of the working channel extension234 is shown with a flange 268 for attaching the working channelextension to the membrane material 38 that is part of the device 10.

Other embodiments will be apparent to those skilled in the art fromconsideration of the specification and practice of the embodimentdisclosed herein. It is intended that the specification and examples beconsidered as exemplary only, with a true scope and spirit of theembodiment being indicated by the following claims.

What is claimed is:
 1. A device for use with an endoscope having aworking channel, the device comprising: a main body comprising avisualization section for allowing viewing of tissue by the endoscopeand a proximal end configured for attachment to a distal end portion ofthe endoscope; a passage within the main body having an exit portal anda proximal end configured for alignment with the working channel of theendoscope; a flexible membrane in contact with, and coupled to, an outersurface of the main body and at least partially surrounding the exitportal; and wherein the device is configured such that an instrumentpassing through the passage is capable of angular adjustment relative tothe main body by actuation of the endoscope.
 2. The device of claim 1,further comprising a working channel extension within the main body, theworking channel extension having an open distal end and a proximal endthat is configured for attachment to the working channel of theendoscope.
 3. The device of claim 2, wherein the proximal end of theworking channel extension is configured for insertion into the workingchannel of the endoscope.
 4. The device of claim 2, wherein the workingchannel extension is flexible and capable of angular adjustment byactuation of the endoscope.
 5. The device of claim 1, wherein the deviceis configured to compress a portion of the passage against theinstrument to secure the instrument in place within the passage.
 6. Thedevice of claim 1, wherein the main body of the device is configured toaccommodate therein an elevator for angular adjustment of theinstrument.
 7. The device of claim 1 further comprising a mechanism forarticulating an instrument passing through the passage.
 8. The device ofclaim 1, wherein the main body comprises an elastic or elastomericmaterial.
 9. The device of claim 1, wherein the endoscope is aside-viewing scope.
 10. The device of claim 1, wherein the endoscopeincludes an elevator for angular adjustment of the instrument.
 11. Thedevice of claim 1, wherein the endoscope includes a cable for angularadjustment of the instrument.
 12. A system comprising: an endoscopehaving a working channel within an elongate shaft; and a coupler devicehaving a main body comprising a visualization section for allowingviewing of tissue by the endoscope and a proximal end configured forattachment to a distal end portion of the endoscope; a passage withinthe main body having an open distal end and a proximal end configuredfor alignment with the working channel of the endoscope; a flexiblemembrane in contact with, and coupled to, an outer surface of the mainbody and at least partially surrounding the exit portal; and wherein thedevice is configured such that an instrument passing through the passageis capable of angular adjustment relative to the main body by actuationof the endoscope.
 13. The system of claim 12, further comprising aworking channel extension within the main body, the working channelextension having an open distal end and a proximal end that isconfigured for attachment to, or insertion within, the working channelof the endoscope.
 14. The system of claim 13, wherein the workingchannel extension is flexible and capable of angular adjustment byactuation of the endoscope.
 15. The system of claim 12, wherein thedevice is configured to compress a portion of the passage against theinstrument to secure the instrument in place within the passage.
 16. Thesystem of claim 12, wherein the main body of the device is configured toaccommodate therein an elevator for angular adjustment of theinstrument.
 17. The system of claim 12, further comprising a mechanismfor articulating an instrument passing through the passage.
 18. Thesystem of claim 12, wherein the main body comprises an elastic orelastomeric material.
 19. The system of claim 12, wherein the endoscopeis a side-viewing scope.
 20. The system of claim 12, wherein theendoscope includes an elevator for angular adjustment of the instrument.21. The system of claim 12, wherein the endoscope includes a cable forangular adjustment of the instrument.